GWP42003 for treatment of schizophrenia or related psychotic disorders
Research type
Research Study
Full title
A double-blind, randomised, placebo-controlled, parallel group study of GWP42003 as adjunctive therapy in the first line treatment of schizophrenia or related psychotic disorder
IRAS ID
141479
Contact name
Philip McGuire
Contact email
Sponsor organisation
GW Research Ltd
Eudract number
2013-000212-22
Research summary
This clinical study is being conducted by GW Research to determine the efficacy and safety of the drug GWP42003 for the symptomatic treatment (as assessed by the Positive and Negative Syndrome Scale [PANSS]) of schizophrenia or related psychotic disorders.
This is a Phase IIa, double-blind, randomised, placebo-controlled, parallel group multicentre study. Participants enrolled into the trial will be randomised on a 1:1 allocation ratio, giving them a 50% chance of receiving active treatment and a 50% chance of receiving placebo. The study is eight weeks long with a treatment period of six weeks.
The study includes four study visits at the study clinic and one safety follow-up visit via telephone. Assessments include questionnaires and interviews to look at positive and negative symptoms (assessed using the PANSS and SANS scales) as well as monitoring functional ability (assessed using the PGIC, CGIC, SAS and GAF scale), cognition (assessed using the BACS scale), dependence disorder (if applicable), adverse events, vital signs, electrocardiogram, Body Mass Index (BMI) and blood/urine samples.
There is a significant unmet medical need in the target population for this study which is highlighted by the fact that over 70% of patients receiving first-line anti-psychotic treatment for schizophrenia, schizophreniform disorder or schizoaffective disorder are clinically stable but nevertheless have a suboptimal response, meaning that they still have significant residual symptoms. It is these residual symptoms this study is designed to target and improve.
For this reason eligible participants will not be required to stop any of their current antipsychotic treatments or medications.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0777
Date of REC Opinion
26 Nov 2013
REC opinion
Further Information Favourable Opinion